Propofol Sandoz 10 mg/ml, emulsie voor injectie of infusie

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

PROPOFOL

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N01AX10

INN (Algemene Internationale Benaming):

PROPOFOL

farmaceutische vorm:

Emulsie voor infusie, Emulsie voor injectie

Samenstelling:

EI FOSFATIDEN, GEZUIVERD ; GLYCEROL (E 422) ; NATRIUMHYDROXIDE (E 524) ; SOJAOLIE, GEZUIVERD ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Propofol

Product samenvatting:

Hulpstoffen: EI FOSFATIDEN, GEZUIVERD; GLYCEROL (E 422); NATRIUMHYDROXIDE (E 524); SOJAOLIE, GEZUIVERD; STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;

Autorisatie datum:

2012-07-06

Bijsluiter

Sandoz B.V.
Page 1/11
Propofol Sandoz
®
10/20 mg/ml, emulsie voor injectie of
infusie
RVG 109287 - 109292
1313-V8
1.3.1.3 Bijsluiter
Februari 2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPOFOL SANDOZ
® 10 MG/ML, EMULSIE VOOR INJECTIE OF INFUSIE
PROPOFOL SANDOZ
® 20 MG/ML, EMULSIE VOOR INJECTIE OF INFUSIE
propofol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you use [nationally completed name]
3.
How to use [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] belongs to a group of medicines called
‘general anaesthetics’. General
anaesthetics are used to cause unconsciousness (sleep) so that
surgical operations or other procedures
can be performed. They can also be used to sedate you (so that you are
sleepy but not completely
asleep).
[nationally completed name] will be given to you as an injection by a
doctor.
[nationally completed name 10 mg/ml
emulsion for injection/infusion]
is used to:
-
Induce and maintain general anaesthesia in adults and children > 1
month
-
Sedate patients > 16 years of age receiving artificial respiration in
intensive care
-
sedate adults and children > 1 month during diagnostic and surgical
procedures, alone or
in combination with local or regional anaesthesia
[nationally completed name 20 mg/ml
emulsion for injection/infusion]
is used to:
-
Induce and maintain general anaesthesia in adults and children > 3
years of age
-
Sedat

Productkenmerken

Sandoz B.V.
Page 1/19
Propofol Sandoz 10/20 mg/ml, emulsie voor
injectie/infusie
RVG 109287-92
1311-V11
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propofol Sandoz 10 mg/ml, emulsie voor injectie of infusie
Propofol Sandoz 20 mg/ml, emulsie voor injectie of infusie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[nationally completed name] 10 mg/ml emulsion for injection/infusion
Each ml emulsion for injection/infusion contains 10 mg of propofol.
Each 20 ml ampoule/vial contains 200 mg of propofol.
Each 50 ml vial contains 500 mg of propofol.
Each 100 ml vial contains 1000 mg of propofol.
[nationally completed name] 20 mg/ml emulsion for injection/infusion
Each ml emulsion for injection/infusion contains 20 mg of propofol.
Each 50 ml vial contains 1000 mg of propofol.
Excipients with known effect:
[nationally completed name] 10 mg/ml emulsion for injection/infusion
Each ml emulsion for injection/infusion contains 100 mg of soya-bean
oil, refined.
Each 20 ml ampoule/vial contains 2 g of soya-bean oil, refined.
Each 50 ml vial contains 5 g of soya-bean oil, refined.
Each 100 ml vial contains 10 g of soya-bean oil, refined.
[nationally completed name] 20 mg/ml emulsion for injection/infusion
Each ml emulsion for injection/infusion contains 100 mg of soya-bean
oil, refined.
Each 50 ml vial contains 5 g of soya-bean oil, refined.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection/infusion.
White or almost white, homogeneous aqueous isotonic oil-in-water
emulsion, practically free of
extraneous particulate contamination and large oil droplets. Slight
creaming may be visible on
prolonged standing.
Osmolality: 285 - 320
mOsm/Kg
pH is in the range of 6.0 – 8.5.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
[nationally completed name 10 mg/ml emulsion for injection/infusion]
Sandoz B.V.
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Propofol Sandoz 10/20 mg/ml, emulsie voor
injectie/infusie
RVG 109287-92
1311-V11
1.3.1.1 Samenva